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Aptive Resources

Project Manager

Silver Spring, MD · On-site

The ideal candidate has FDA CDER expertise and is familiar with their administrative and program execution activities. They have previous experience leading projects and are highly organized and ...

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How much do fda cder jobs pay per year?

As of Jun 6, 2026, the average yearly pay for fda cder in the United States is $78,419.00, according to ZipRecruiter salary data. Most workers in this role earn between $61,000.00 and $90,500.00 per year, depending on experience, location, and employer.

What is an FDA CDER job?

An FDA CDER job refers to a role within the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). CDER is responsible for ensuring the safety, effectiveness, and quality of human drugs. Jobs in CDER can include roles in drug review, regulatory science, pharmacology, and policy development. Employees work to evaluate new drug applications, monitor post-market drug safety, and develop guidelines to improve public health. Positions may require expertise in medicine, pharmacy, biology, chemistry, or regulatory affairs.

What are the key skills and qualifications needed to thrive in the Fda Cder position, and why are they important?

To thrive in a role within the FDA's Center for Drug Evaluation and Research (CDER), you typically need a background in pharmaceutical sciences, regulatory affairs, medicine, or related scientific fields, often with an advanced degree such as a PharmD, PhD, or MD. Familiarity with regulatory guidelines (e.g., FDA, ICH), submission management systems, and data analysis tools is commonly required, along with certifications like RAC (Regulatory Affairs Certification) being beneficial. Exceptional analytical thinking, attention to detail, and effective written and verbal communication skills help professionals excel in multidisciplinary team settings. These competencies are essential for ensuring thorough drug evaluation, compliance with regulations, and safeguarding public health.

What are the typical daily responsibilities of someone working at FDA CDER?

At FDA CDER, typical daily responsibilities include reviewing data from drug development and clinical trials, preparing and assessing regulatory submissions, and collaborating closely with colleagues across scientific, legal, and public health disciplines. Professionals may participate in meetings to discuss safety or efficacy issues, draft guidance documents, and respond to inquiries from pharmaceutical companies. Teamwork and cross-disciplinary communication are frequent given the complexity of regulatory decisions. The work is highly detail-oriented and focuses on ensuring that medications are safe and effective for public use.

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Fda Cder jobs near you
Infographic showing various Fda Cder job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 71% In-person, and 29% Remote job distribution, with an average salary of $78,419 per year, or $37.7 per hour.
Regulatory Affairs Principal, Pharmaceutical and Combination Products

Regulatory Affairs Principal, Pharmaceutical and Combination Products

Meridian Bioscience, Inc.

Remote

Other

Posted 28 days ago

Job description

About Meridian
Meridian Bioscience is a fully integrated life science company developing and delivering innovative diagnostic and life science solutions that improve patient outcomes worldwide. Our work spans discovery to diagnosis, and we are expanding into combination drug-device products that redefine how diseases are detected and managed.
We are seeking a Regulatory Affairs Principal to play a key role in advancing our pipeline, including the BreathID platform-a unique combination product at the intersection of pharmaceuticals and diagnostics.
Job Summary
The Regulatory Affairs Principal will provide strategic regulatory leadership to support the development, approval, and lifecycle management of pharmaceutical and combination drug-device products. This individual will serve as a key regulatory partner to cross-functional teams, with a primary focus on FDA CDER interactions, IND/NDA submissions, and global regulatory strategy.This is a high-impact role for a regulatory professional who thrives in a collaborative environment and wants to shape regulatory strategy for innovative combination products.
Key Duties
  • Lead and contribute to regulatory strategy for pharmaceutical and combination products across development and lifecycle stages
  • Author and review INDs, NDAs, supplements, and other global regulatory submissions
  • Serve as a primary interface with FDA CDER, including leading preparation for and participation in agency meetings (e.g., Type B/C)
  • Develop and deliver high-quality briefing documents, responses, and regulatory communications
  • Provide regulatory guidance on clinical, nonclinical, and CMC development activities
  • Drive combination product regulatory strategy, including coordination with FDA's Office of Combination Products (OCP)
  • Advise on labeling strategy, including prescribing information and device components of combination products
  • Assess regulatory impact of development and post-approval changes and define appropriate regulatory pathways
  • Support global regulatory activities, including submissions and interactions with ex-U.S. health authorities (e.g., EMA)
  • Stay current on evolving regulatory requirements and translate them into actionable guidance for teams
  • Mentor and provide guidance to junior regulatory team members

Qualifications
Experience
  • 7+ years of regulatory affairs experience in pharmaceuticals, biotechnology, or combination products
  • Proven experience with FDA CDER submissions, including INDs, NDAs, and/or supplements
  • Demonstrated success interacting with FDA, including meeting preparation and regulatory strategy execution
  • Experience with combination products (drug-device) strongly preferred
  • Working knowledge of U.S. regulatory requirements (21 CFR 210/211, Part 4) and relevant FDA guidance
  • Exposure to global regulatory environments (e.g., EMA, ICH) preferred

Education
  • Bachelor's degree in a scientific discipline required
  • Advanced degree (MS, PhD, PharmD) preferred

Certifications
  • RAC (US or Drugs) preferred

Travel
  • 0-10%

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